Study Completed

Pain, Postoperative

Bayer Identifier:

19762

ClinicalTrials.gov Identifier:

NCT03404206

EudraCT Number:

2017-005049-67

EU CT Number:

Not Available

A Trial to Compare the Duration of Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Ibuprofen Tablets in Postsurgical Dental Pain

Trial purpose

To compare the duration of analgesic efficacy as determined by the time to rescue medication of a single oral dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo over 24 hours in subjects experiencing moderate to severe post-impaction surgery dental pain.
To compare the overall analgesic effect (SPID 0-24) of a single dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo.
To compare the overall relief from pain (TOTPAR 0-24) of a single dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo.

Key Participants Requirements

Sex

All

Age

16 - 40 Years

Inclusion Criteria
- Healthy, ambulatory, male or female volunteers 16-40 years of age;
- Body mass index 18.0 to 30.0 kg/m^2 inclusive;
- Scheduled to undergo surgical removal of at least 2 mandibular partial or full bony impacted third molars. Up to two maxillary third molars may be removed regardless of impaction level. Supernumerary teeth present may also be removed at the discretion of the oral surgeon;
- Mandibular molars must demonstrate modified Demirjian root classification stage D, E, F, G or H;
Exclusion Criteria
- History of hypersensitivity to naproxen sodium, ibuprofen, nonsteroidal anti-inflammatory drugs (NSAIDS), aspirin, similar pharmacological agents, local anesthetics, rescue medication or components of the investigational products;
- Evidence or history of clinically significant (in the judgment of the investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies within the last 5 years;
- Relevant concomitant disease such as asthma (exercise induced asthma is permitted)

Trial summary

Enrollment Goal

387

Trial Dates

February 2018 - July 2018

Phase

Phase 4

Could I Receive a placebo

Yes

Products

Aleve (Naproxen Sodium, BAY117031)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Jean Brown Research	Salt Lake City, 84124, United States
Completed	Jean Brown Research	Salt Lake City, 84124, United States

Primary Outcome

Time to first use of rescue medication
Time to first use of rescue medication was estimated using Kaplan-Meier method. If a subject did not take the rescue medication during the treatment period, (s)he was censored at the time of last assessment.
Time Frame:
Up to 24 hours

Secondary Outcome

Sum of Pain Intensity Difference (SPID)
Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score – post-baseline score). A positive difference was indicative of improvement. Time-weighted sum of pain intensity differences (SPIDs) were calculated by multiplying the PID score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values.
Time Frame:
Up to 24 hours
Total Pain Relief (TOTPAR)
Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values.
Time Frame:
Up to 24 hours

Trial design

A Randomized, Double-Blind, Placebo-Controlled Trial to Compare the Duration of Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Ibuprofen Tablets in Postsurgical Dental Pain

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

N/A

Assignment

Parallel Assignment

Trial Arms

Additional Information

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